Sudden Hearing Losses Prompt Label Change for PDE5 inhibitors

ROCKVILLE, Md., Oct. 22 -- The FDA has approved label revisions for PDE5 inhibitors to reflect an association with a small number of patients developing a sudden hearing loss, both with and without vestibular symptoms.

The FDA said it found 29 reports of sudden hearing loss, sometimes temporary, associated with the erectile dysfunction agents after scouring the Adverse Event Reporting System. The search was triggered by a case report in the April 2007 issue of the Journal of Laryngology & Otology that discussed the hearing loss of a man taking Viagra (sildenafil).

The approved FDA changes in labels of sildenafil, Cialis (tadalafil), and Levitra (vardenadil) included a new precaution and an updated adverse reactions sections. There have also been cases of sudden hearing loss reported in patients using Revatio (sildenafil) for pulmonary arterial hypertension, and a label change for that agent is also in the works,

Though no causal relationship has been demonstrated, the FDA believes that the "strong temporal relationship between the use of PDE5 inhibitors and sudden hearing loss in these cases warranted revisions to the product labeling for the drug class."

In most of the cases, the hearing loss involved one ear, said the FDA. The hearing loss was either a partial or complete loss of usual hearing.

"In approximately one third of cases, the event was temporary," said the FDA. "In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described."

The FDA also pointed out that "because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it."

The FDA added, "Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention." Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation."